Efficacy Study of Adalimumab to Treat Interstitial Cystitis - Full Text View

Purpose

The purpose of this study is to evaluate an investigational treatment for interstitial cystitis. Interstitial cystitis is a chronic bladder disease that includes the following symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and bladder discomfort relieved by voiding.

Presently, there is no cure for interstitial cystitis. The response to current treatments is poor. Patients with interstitial cystitis have a poorer quality of life. The cause of interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for improving the symptoms of patients with interstitial cystitis. Humira® is an injectable anti-inflammatory medication that has been available for use since December 31, 2002. Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial cystitis. This study will evaluate an investigational use of Humira® for the treatment of interstitial cystitis.

Condition	Intervention	Phase
Interstitial Cystitis	Drug: Adalimumab Other: inactive drug	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by ICStudy, LLC:

Primary Outcome Measures:

O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score [ Time Frame: Baseline/12 Weeks ] [ Designated as safety issue: No ]
Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)

Secondary Outcome Measures:

Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: Baseline/ 12 weeks ] [ Designated as safety issue: No ]
Improvement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms)
Interstitial Cystitis Problem Index (ICPI) [ Time Frame: Baseline/12 Weeks ] [ Designated as safety issue: No ]
Improvement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms)
Pelvic Pain Urgency/Frequency (PUF) Score [ Time Frame: Baseline12 Weeks ] [ Designated as safety issue: No ]
Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)
Global Response Assessment (GRA) [ Time Frame: Measured at12 Weeks ] [ Designated as safety issue: No ]
Percent(%) of patients who reported 50% or greater overall improvement in their condition.

Score on a scale range (improvement 0%-100%)


Enrollment:	43
Study Start Date:	March 2011
Study Completion Date:	July 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: adalimumab Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks	Drug: Adalimumab 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period Other Name: Humira
Placebo Comparator: Inactive drug Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks	Other: inactive drug 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period Other Name: placebo

Detailed Description:

Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary frequency, nocturia, urinary urgency, and pain with bladder filling—relieved by emptying. There is no cure for IC and the treatment options are suboptimal. Patients with IC report significant negative effects on their physical and mental quality of life. The etiology of IC is unknown. Certain aspects of IC suggest that autoimmunity may play a role in initiating or sustaining the chronic inflammatory response. Bladder biopsies of patients with IC demonstrate an increase number of mast cells. Mast cell activation with the release of tumor necrosis factor (TNF) may mediate this bladder inflammation. Humira® (adalimumab) is a medication that blocks the effect of TNF. Humira® (adalimumab) is FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases are similar to IC. In this study, the hypothesis being tested is that Humira® (adalimumab) will show efficacy at reducing the symptoms of IC.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females ≥18 and ≤ 65 years of age previously diagnosed with Interstitial Cystitis
Currently have symptoms of urinary urgency, frequency or pain for more than 6 months
Urinating at least 7 times a day or having some urgency or pain (measured on linear analog scales)
Must be post-menopausal or surgically sterile or willing to use an adequate form of birth control
Not pregnant or lactating
Capable of voiding independently
Willing to provide informed consent to participate

Exclusion Criteria:

Have symptoms that are presently relieved on other medications for interstitial cystitis
Have absence of nocturia
Have symptoms that are relieved by antimicrobials or antibiotics.
Have a body mass index (BMI) of >39 kg/m2
Have uncontrolled hypertension
Have Type I or type 2 diabetes
Have active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B) at Screening
Have a positive tuberculosis test at screening
Have had a urinary tract infection for 6 weeks
Have had bacterial cystitis in previous 3 months
Have had previous exposure to Humira® (adalimumab)
Have taken investigational medication within 30 days of screening
Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
Are unable or unwilling to comply with protocol requirements

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295814

Locations


United States, California
Philip C. Bosch, MD
Escondido, California, United States, 92025

Sponsors and Collaborators

ICStudy, LLC

Abbott

Investigators


Principal Investigator:	Philip C Bosch, MD

More Information

Publications:

Bosch PC. A randomized, double-blind, placebo controlled trial of adalimumab for interstitial cystitis/bladder pain syndrome. J Urol. 2014 Jan;191(1):77-82. doi: 10.1016/j.juro.2013.06.038. Epub 2013 Jun 20.


Responsible Party:	Philip C. Bosch, M.D., Urologist, ICStudy, LLC
ClinicalTrials.gov Identifier:	NCT01295814 History of Changes
Other Study ID Numbers:	IMM 10-0061
Study First Received:	February 14, 2011
Results First Received:	July 20, 2013
Last Updated:	July 12, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by ICStudy, LLC:


Interstitial cystitis Humira Adalimumab

Additional relevant MeSH terms:


Cystitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases	Adalimumab Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on September 29, 2016